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Data / Medical devices / Stirrup, External Brace Component

Stirrup, External Brace Component (ITC): 29 FDA-registered makers in 11 countries

29 establishments in 11 countries are registered with the FDA to make Stirrup, External Brace Component (product code ITC, Class 1, 21 CFR 890.3410). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ITC
Device class
1
Regulation
890.3410
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States13
China6
Mexico2
Netherlands1
Vietnam1
India1
Belgium1
Taiwan1
Germany1
Thailand1
United Kingdom1

Makers of Stirrup, External Brace Component

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Basko Healthcare B.V.ZAANDAM Noord-Holland, NetherlandsComplaint file establishment, Exporter to the US, Manufacturer, Specification developer0000api.fda.gov
Becker Orthopedic Appliance Co.Troy, MI, United StatesManufacturer0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesContract manufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dongguan SAVA Sporting Products Co.,LtdDongguan City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Elite Orthopaedics, Inc.South El Monte, CA, United StatesManufacturer0000api.fda.gov
Fillauer, LLCChattanooga, TN, United StatesManufacturer0000api.fda.gov
Guangdong Hexin Technology Weaving Co., LTDHuizhou City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
GuoLong (Shenzhen) High Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Hameco Hy Co., LtdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
J & D Tech IncNesconset, NY, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Maquiladora De Coahuila S De RL De CVCUIDAD ACUNA Coahuila, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Northeast Medical Systems And Design, LLCCherry Hill, NJ, United StatesManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Orfit Industries NVWIJNEGEM Antwerpen, BelgiumManufacturer0000api.fda.gov
Overland Int'l CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyManufacturer, Specification developer0000api.fda.gov
Restorative Care Of America, Inc.Saint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Secure Manufacturing (thailand) Co., Ltd.Bangkok Krung Thep Maha Nakhon, ThailandManufacturer0000api.fda.gov
Secured Ortho Manufacturing Of America, LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Span Link International LLCDeer Park, NY, United StatesSpecification developer0000api.fda.gov
ST&G Usa Corporation / ChoiBrea, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Trulife, Ltd.S. Yorkshire Sheffield, United KingdomManufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.